Biktarvy, which is based on the new integrase inhibitor bictegravir, was approved by the Food and Drug Administration in February for use among adults living with HIV. The tablet is not approved for those who have a creatinine clearance below 30 milliliters per minute, indicating severe kidney impairment, or those with severe liver impairment. There are insufficient safety data regarding its use among pregnant women.

The panel based its recommendation on clinical trials that found that Biktarvy was effective, well tolerated and noninferior to—meaning it treats HIV as effectively as—two other regimens based on the integrase inhibitor Tivicay (dolutegravir): Triumeq (dolutegravir/abacavir/lamivudine) or Tivicay plus Descovy (emtricitabine/tenofovir alafenamide).